PharmaLand Consulting Group Information

From the seeds of knowledge fruits of science grow. ™ PharmaLand Consulting Group is focused on statistical, scientific and regulatory consulting in metabolic disorders, genitourinary diseases, gastroenterology, respiratory and allergy, CNS, cardiology, dermatology, and oncology, with a special focus on rare diseases. We also advise in the area of medical devices, OTC medicines, in particular Rx to OTC switches, and nutraceuticals. Here is what we do! Clinical due diligence services with the emphasis of statistical data review and re-analysis. Scientific and statistical consulting on clinical development plans, study design and analysis. Strategic regulatory consulting including gap analysis of existing data packages. Participation on Data Safety and Monitoring Boards. Data re-analysis. Data mining. Advice on submission content and review of integrated submission documents. Advice on regulatory issues including participation in FDA meetings. Advice on post approval research including Real World Evidence, disease registries, observational studies, and retrospective data analysis. Scientific publications with emphasis on statistical advice to support claims, value proposition, and reimbursement. Executive advice on R&D structure, outsourcing options and FSP (functional service provider) setup. Advice to pharmaceutical vendor organizations on business development and investment strategies. At the core of your efforts. Your worries stop where we begin. ™